BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE

    MDR report key: 2008036 · Received March 4, 2011

    Report

    Report Number
    2050012-2011-00582
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CHI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM DXC 600 PRO, TO: N/A. FROM: K042291, TO: N/A.

    Additional Manufacturer Narrative · 1

    A REPLACEMENT REAGENT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT LIPASE REAGENT CARTRIDGE LEAK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE LIPASE ENZYME IMMUNOASSAY CHI BECKMAN COULTER INC. N/A M011436

    Patients

    Seq Age Sex Outcome Treatment
    1